Continuous Processing: Is The Pharma Industry Finally Coming Round To The Idea? - Pharmaceutical Technology

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PharmTech Europe

Continuous Processing: Is The Pharma Industry Finally Coming Round To The Idea?

Pharmaceutical Technology Europe
Volume 22, Issue 9

Q. PTE: What challenges does implementing continuous processing technologies present? How can they be minimised or overcome?

Kris Schoeters
Nepveux (Pfizer): As discussed earlier, I believe that start-up/shutdown of a process can present a challenge because of product loss at the beginning and end of these stages using continuous processing.

Schoeters (GEA): If I call upon my personal experience with the challenges that I have witnessed with our own ConsiGma technology, when using this technology from Intermediate Bulk Container (IBC) to IBC ("batch mode") we believe — and this has been confirmed by regulatory authorities — there will be a small impact from a validation point of view. When switching to the full continuous ConsiGma tabletting line, including advanced process controls and real-time release, the challenge will be the (perceived) regulatory hurdle. This can, however, be tackled by working closely together with the authorities, such as FDA and EMA, during the development or transfer phase.

Weiler (SAFC): Solid formation in general can block the reaction channels and is difficult to overcome; this occurs in 5–10% of our new process developments. Further, although continuous processing is reliable and minimises total reaction time and work-up volume, experienced and specialised personnel are required to develop efficient flow chemistry protocols; this is not typically part of a chemist's current thinking.

Another issue that needs to be addressed is the lack of definition; if a continuous process is used in the pharmaceutical industry the definition of a batch size needs to be discussed and agreed with the regulatory authorities.

Moreover, implementing continuous processing requires a change in processes that have already been validated.

These factors present a challenge to manufacturers who are seeking to implement continuous process technologies. Long term this challenge will be overcome if the cost savings are sufficient to justify the process change and if the regulatory authorities are supportive in implementing continuous processes.

Whitfield (Inprotech): Fundamentally, I believe within many pharma companies, there is a philosophical leap of faith issue to be addressed, born principally out of regulatory and technology uncertainty. Additionally, one of the main challenges is that, after more than 20 years of megamergers and acquisitions, most of the Big Pharma companies have surplus batch-based capacity and an equipment asset base that requires compelling business cases to writeoff and replace with continuous process technologies. During these times of economic uncertainty and costcutting measures, such technology investment strategies have become even more demanding.

To reassure wouldbe company decisionmakers that these continuous processing technologies are robust and will deliver the welldocumented business benefits, there is undoubtedly a need for more evidence, probably in the form of active demonstrators. One successful, fully operational demonstrator system has been established by a UK-based consortium, called Advanced Secondary Pharmaceutical Manufacturing, which is part-funded by the UK's Technology Strategy Board. The consortium involves two key European technology vendors (GEA and Siemens), two UK universities (Newcastle and Warwick) and is led by GlaxoSmithKline. Using the continuous process operations of dispensing, blending, high shear granulation, fluid bed drying, continuous product evaluation and compression, tablets are produced from powders in tens of minutes, compared with typically tens of hours in batch-based OSD processes. The F3 Factory (EU-funded) project will deliver a modular, continuous chemical plant demonstrator at Bayer's Leverkusen facility, using advanced microreactor technologies, such as the Ehrfeld Mikrotechnik "MMRS" units.

Robust, compelling and also creative business cases, which strongly support the investment in continuous processing technology and the disposal of traditional batch-based assets, can be developed by adopting a more holistic, business-integrated approach, which considers not just manufacturing benefits but also those presented to R&D and commercial divisions. Technology value roadmapping, for example, can be utilised to enhance discounted cash flow business cases.


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